Monitoring the stability of the standardization status of FT4 and TSH assays by use of daily outpatient medians and flagging frequencies
Open accessAbstract
Clinicians diagnose thyroid dysfunction based on TSH and FT4 testing. However, the current lack of comparability between assays limits the optimal use of laboratory data. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) gave a mandate to the Committee for Standardization of Thyroid Function Tests (C-STFT) to resolve this limitation by standardization. Recently, the Committee members and their partners felt ready to set the step towards the technical recalibration. However, before implementation, they were furthered by the Food and Drugs Administration (FDA) to develop a tool to assess the sustainability of the new calibration basis. C-STFT began to use 2 online applications, i.e., the "Percentiler" and "Flagger", with the intention to assess their utility for this purpose. The tools monitor the course of instrument-specific moving medians of outpatient results (Percentiler) and flagging rates (Flagger) from data of individual laboratories grouped by instrument/assay peer. They additionally document the mid- to long-term medians, hence, are quality indicators of stability of performance of both laboratories and peers/assays. Here, the first experiences built up in the pre-standardization phase are reported. They suggest the suitability of both applications to document the sustainability of the calibration basis in the post-standardization phase.
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State-of-the-art APS can be derived from evaluation and comparison of laboratory methods or from peer comparison data from proficiency testing programs.
“Alternatively, the state-of-the-art APS can be derived from the evaluation and comparison of laboratory methods99–104 or using peer comparison data from proficiency testing programs.105–107”
From Thyroid Stimulating Hormone and Thyroid Hormones (Triiodothyronine and Thyroxine): An American Thyroid Association-Commissioned Review of Current Clinical and Laboratory Status (2023) · cites this paper as [105]
The Discussion (page unavailable) describes comparisons among assay methods and laboratory peer groups, and mentions external quality-assurance programs that produce method-trend data. It does not say that state-of-the-art analytical performance specifications are derived from those comparisons or from proficiency-testing data. The Material and methods section instead says this study’s desirable bias limits came from biological variation. (LLM, conf=0.78)
Experimental — accuracy not yet measuredAdditional information about accuracy and quality of fT4 and TSH assays can be derived from outpatient data or from anonymized electronic patient records.
“Additional information can be derived from outpatient data (e.g., the Noklus Percentiler105,120), or from anonymized electronic patient records.”
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References 24 · Cited by 15
- Authors
- De Grande, L. A. C., Goossens, K., Van Uytfanghe, K., Das, B., MacKenzie, F., Patru, M.-M., & Thienpont, L. M.
- Affiliations
- Ghent University (BE)
- Kokilaben Dhirubhai Ambani Hospital (IN)
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Corresponding author
- Thienpont, Linda M.
- Venue
- Clinica Chimica Acta
- Publisher
- Elsevier BV
- Published
- 2017-04
- Volume
- 467
- Pages
- 8-14
- ISSN
- 0009-8981 (ISSN-L)
- OpenAlex
- W2344007603
- Cited by
- 15
- References
- 24
- Citations by year
- 2026: 1 · 2025: 1 · 2023: 2 · 2022: 1 · 2021: 1 · 2020: 1 · 2019: 2 · 2018: 2 · 2017: 3 · 2016: 1
- FWCI
- 2.14
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinica Chimica Acta (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
- Keywords
- assay standardization, assay comparability, moving median, laboratory quality indicators
- MeSH terms
- Blood Chemical Analysis, Humans, Outpatients, Reference Standards, Thyrotropin, Thyroxine, Time Factors
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